Control of impurities of pharmacopoeial substances

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCPMP/QWP/1529/04
Published22/04/2004
Effective from22/04/2004
KeywordsActive substance, impurities, pharmacopoeial substances, European Pharmacopoeia, monograph, certificate of suitability (CEP)   
DescriptionThis document aims to facilitate compliance with the European Pharmacopoeia requirements set out in general monograph 'Substance for pharmaceutical use' and general chapter 'Control of impurities in substances for pharmaceutical use'. It provides guidance to applicants who are encountered with so called old monographs during marketing authorisation process.   


Related content


How helpful is this page?

Average rating:

 Based on 5 ratings

Add your rating:

See all ratings
2 ratings
0 ratings
0 ratings
0 ratings
3 ratings
    

Tell us more